FDA DRUG ADVISORY COMMITTEES SHOULD NOT BE DISMANTLED, NDMA URGES

FDA DRUG ADVISORY COMMITTEES SHOULD NOT BE DISMANTLED, NDMA URGES Office of Management & Budget Director Leon Panetta in an April 16 letter. In response to a Feb. 10 executive order by President Clinton that each department and agency terminate not less than one-third of advisory committees ("The Tan Sheet" April 5, In Brief), Nonprescription Drug Manufacturers Association President James Cope asked that "this order not be applied to dismantle FDA's drug advisory committees, which are critical to the agency's obligation to assure that marketed drugs are safe and effective." Dismantling one-third of FDA's advisory committees "would be irrational," NDMA declared. The committees provide FDA with "unique sources of expertise to inform the agency's decision- making and expedite approval of life-saving and cost-saving therapies." The independent scientific judgment provided by the committees "could not readily be duplicated by other means," NDMA pointed out, adding: "The drug regulatory review system should not be compromised." NDMA asserted that the OTC Drugs Advisory Committee in particular "contributes to public health protection and produces cost savings" by "evaluating prescription drug candidates for switch to over-the-counter status." The Rx-to-OTC switch, NDMA continued, "represents the single greatest opportunity to empower consumers to care for themselves." In addition, OTC drugs "constitute the most cost-effective portion of health care," the association said. The OTC Drugs Advisory Committee "helps to focus and expedite FDA's OTC decision-making, a net savings for agency resources" and, therefore, should be exempt from the executive order, the association concluded. In a similar letter to HHS Assistant Secretary for Health- designate Philip Lee, MD, the Pharmaceutical Manufacturers Association maintained that reducing the number of FDA advisory committees could affect "the safety of new drugs and biologics, would increase the review time for FDA applications and ultimately have a negative public health impact in the U.S." PMA also urged HHS to heed the recommendations of a 1992 Institute of Medicine report that stated that FDA's advisory committee system "is fundamentally sound, has served the agency well and does not need wholesale reorganization." FDA and HHS are in discussions about how FDA's advisory committee system can be downsized. HHS is working under a May 10 deadline to send recommendations to OMB. The cuts are to be made by the end of fiscal 1993 in committees that are subject to the Federal Advisory Committee Act and not required by statute, the executive order says. Each FDA center and office has drawn up a list of options for cuts. Some of the options include: cutting some or all of the committees; combining committees; and decreasing the frequency of meetings. One strategy suggested to meet the cost reduction target sought by the administration would be to limit advisory committee meetings to government facilities while reducing expenses an additional 5-15%. Ann Witt, special assistant to Deputy Commissioner for Operations Jane Henney, is coordinating the review of advisory committee cuts at FDA at the same time she is directing FDA's effort to implement the IoM recommendations for improving the advisory committee process. The agency has set up working groups that involve members of committee management in each center to evaluate the IoM recommendations. FDA expects the working groups to complete their evaluations by late 1993/early 1994.